Back to resultsPhase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
Primary Purpose
Pruritus, Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SRD174 Cream
vehicle cream
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus, Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Males and females aged 18 years and over moderate to severe AD pruritus
- Written signed and dated informed consent
- Satisfactory medical assessment with no clinically relevant abnormalities
Exclusion Criteria:
- Subject with active and pruritic AD covering a body surface area (BSA) > 20%
- Subject with severe AD defined as an IGA score of 4
- Subject with current or recurrent skin disease (except AD) that could affect the site of application of action, absorption or disposition of the investigational product, or clinical, laboratory assessments.
- Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- Subject with known or suspected intolerance or hypersensitivity to the Investigational products or any of the stated ingredients.
- Subject who has a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with interpretation of trial results and, in the judgment if the investigator, would make the subject inappropriate for entry into this trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Vehicle cream
SRD174 Cream
Arm Description
Outcomes
Primary Outcome Measures
Measure of intensity and duration of itch episodes
Secondary Outcome Measures
Safety and local dermal tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00838708
Brief Title
Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
Official Title
A Phase II, Randomised, Double-blind, Vehicle-controlled, Cross-over Study to Determine the Anti-pruritic Efficacy, Safety and Local Dermal Toleration of SRD174 Cream in Subjects With Atopic Dermatitis.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Serentis Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pruritus is an essential feature for the diagnosis of atopic dermatitis and may play an important part in disease progression. Itching has a significant impact on the quality of life of AD sufferers, in particular night-time itching leading to sleep disturbance and subsequent poor daytime performance.
The objective of this study is to determine whether SRD174 Cream is a safe and effective therapy for moderate to severe pruritus associated with atopic dermatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle cream
Arm Type
Placebo Comparator
Arm Title
SRD174 Cream
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SRD174 Cream
Intervention Description
topical SRD174 Cream
Intervention Type
Other
Intervention Name(s)
vehicle cream
Intervention Description
topical vehicle cream
Primary Outcome Measure Information:
Title
Measure of intensity and duration of itch episodes
Time Frame
Duration of episode
Secondary Outcome Measure Information:
Title
Safety and local dermal tolerability
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females aged 18 years and over moderate to severe AD pruritus
Written signed and dated informed consent
Satisfactory medical assessment with no clinically relevant abnormalities
Exclusion Criteria:
Subject with active and pruritic AD covering a body surface area (BSA) > 20%
Subject with severe AD defined as an IGA score of 4
Subject with current or recurrent skin disease (except AD) that could affect the site of application of action, absorption or disposition of the investigational product, or clinical, laboratory assessments.
Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
Subject with known or suspected intolerance or hypersensitivity to the Investigational products or any of the stated ingredients.
Subject who has a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with interpretation of trial results and, in the judgment if the investigator, would make the subject inappropriate for entry into this trial.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Hot Springs
State/Province
Arkansas
Country
United States
City
Oceanside
State/Province
California
Country
United States
City
Ormond Beach
State/Province
Florida
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Grand Blanc
State/Province
Michigan
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Hazleton
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Lynchburg
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
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